CHART, AMSLER RECORD

The contract mandates the procurement of CHART, AMSLER RECORD, a medical supply item identified by NSN 6540-01-079-3516, furnished in pads of 50 sheets each, for use in recording patient grid chart scores. It is classified as a Class I medical device under FDA Regulation 886.1330, requiring compliance with registration, labeling, and GMP standards, though a 510(k) premarket notification is not required. Delivery is due within 20 days ADO, with FOB Destination terms specifying delivery to APO Zip 09094-3219. Packaging and marking must adhere strictly to Commercial standards and Medical Marking Standard No. 1, which supersedes MIL-STD-129, ensuring each unit is sealed in a protective container and shipped in suitable exterior packaging capable of safe transport via common carrier at the lowest cost. All materials must be labeled according to MMS No. 1, and copies of the standard are available via DLA Troop Support. Technical and quality specifications are governed by the DLA Master List of Technical and Quality Requirements, with non-accepted supplies requiring removal of government identification. The solicitation, issued under SPE2DS-26-T-111H, is a simplified acquisition using the DIBBS platform, with bids due by June 8, 2026, and is subject to the Buy American Act and Berry Amendment, with no small business set-aside. Payment must be processed electronically via WAWF using invoice and receiving report formats appropriate for fixed-price line items, and contractors must comply with comprehensive federal requirements including employment eligibility verification, combating trafficking in persons, sustainable products, hazardous materials handling, cybersecurity safeguards under NIST SP 800-171, and SAM registration. Deviations to several FAR and DFARS clauses are in effect, primarily under Deviation 2026-00038, and suppliers must affirm their socioeconomic status, including small business, WOSB, SDVOSB, or HUBZone certifications if applicable, while ensuring no covered telecommunications equipment or services from prohibited Chinese entities are provided. The item is regulated under FDA Class I, and the contracting office is the Medical Supply Chain MD SURG FSF under the Department of Defense.